A significant health concern to many individuals is the problem of high cholesterol. While many medications are available for treating this problem, most of the common medications require doctor's supervision for use and are frequently relatively expensive. Certainly a doctor's care and use of these medications in cases of highly elevated or chronically elevated cholesterol are very important but the medications are used when the cholesterol level is a serious health threat.
Some herbal/natural vitamin and/or mineral and/or nutritional compositions that contain phytosterols, compounds that are believed to facilitate cholesterol reduction, are commercially available. However, the efficiency of these herbal/natural product compositions for reducing cholesterol is questionable as they typically contain 20 to 50 mg of phytosterol per dose. This is substantially below the amount that the FDA (Food and Drug Administration) recognizes as an efficacious dose of phytosterol for reducing cholesterol levels. In 21 CFR 101.83, and the FDA sterol enforcement discretion letter dated Feb. 14, 2003, the FDA indicates that 800 mg/day is the lowest effective intake of the phytosterols to reduce risk of coronary heart disease.
In addition to the amount of phytosterol the FDA recommends being a sizable amount of material, phytosterol is a waxy material that is believed to be efficacious in the digestive system in a particulate form. Typically, compressing phytosterol to form a tablet results in formation of a waxy lump or lumps that do not disintegrate in a timely manner. McPherson et al. address the difficulties of tableting free base phytostanols in the Journal of Pharmacy and Pharmacology 2005, 57; 889-896. In order to obtain an efficacious dose of stanols, the authors were forced to split their daily dosage into 6 tablets. The difficulties McPherson encountered in tableting free phytostanols are similar to those encountered when tableting phytosterols.
It would be desirable to have a convenient, practical and relatively inexpensive way to tablet phytosterol for dietary supplementation to facilitate reducing cholesterol levels, and/or reducing homocysteine, and/or decreasing low-density lipoprotein-cholesterol (LDL-C) oxidation in humans before the cholesterol reaches a level to become a serious health threat.